BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGNISHIELD STOOL MANAGEMENT SYSTEM

    MDR report key: 3932035 · Received June 20, 2014

    Report

    Report Number
    1018233-2014-00157
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KNT
    PMA / PMN Number
    K102391
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING AND THE PT DEVELOPED AN ULCER/PRESSURE SORE AROUND THE AREA IN CONTACT WITH THE TOP OF THE TUBING. THE PT WAS THEN TRANSFERRED TO A SPECIALITY HOSPITAL DUE TO THEIR CO-MORBIDITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362407 DIGNISHIELD STOOL MANAGEMENT SYSTEM KNT PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention